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NCT Number: NCT06571383

STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cliniques universitaires Saint-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study:
  • The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
  • The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements
  • Age 12 to less than 15 years at the time of signing the informed consent
  • BMI greater than or equal to 95th percentile at screening
  • Body weight greater than 60 kg at screening

Exclusion criteria

  • Prepubertal status (Tanner stage 1)
  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
  • Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
  • Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
  • Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
  • Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
  • Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening
  • Endocrine, hypothalamic, or syndromic obesity
  • History of type 1 or type 2 diabetes mellitus

Treatment and study plan

semaglutide

Drug

Participants will receive semaglutide s.c(under the skin) once weekly.

Primary outcomes

  1. Maintenance of Body Mass Index (BMI) below obesity threshold

    Time frame: From 1.5 years to 3 years

    Measures as count of participants

Secondary outcomes

  1. Maintenance of improved Body Mass Index (BMI) category

    Time frame: From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

    Measured as count of participants

  2. Tapering to zero dose

    Time frame: From 1.5 years to 3 years

    Measured as count of participants

  3. Time/dose steps before ending dose tapering

    Time frame: From 1.5 years to 3 years

    Measured in weeks, count of dose steps

  4. Achieving Body Mass Index (BMI) below obesity threshold

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured as count of participants

  5. Achieving any improvement in Body Mass Index (BMI) category

    Time frame: From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)

    Measured as count of participants

  6. Change in Body Mass Index (BMI)

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Measured in percentage (%)

  7. Body Mass Index (BMI) percentage of the 95th percentile

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Measured in percentage (%)

  8. Change in Body Mass Index Standard Deviation Score (BMI SDS)

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Unitless

  9. Change in waist-to-height ratio (waist [cm]/ height [cm])

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Unitless

  10. Change in waist circumference

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Measured in centimeters (cm)

  11. Change in HbA1c

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured in percentage (%) points

  12. Change in fasting plasma glucose

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL)

  13. Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured in percentage (%)

  14. Change in high sensitivity C-reactive protein (hsCRP)

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured in percentage (%)

  15. Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured in percentage (%)

  16. Change in systolic and diastolic blood pressure

    Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

    Measured in millimetres of mercury (mmHg)

  17. Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Measured in percentage (%) points

  18. Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Measured in percentage (%) points

  19. Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)

    Time frame: From baseline (day 0) to 1.5 and 3 years

    Measured in percentage (%)

  20. Serious Adverse Event (SAE)

    Time frame: From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years)

    Count

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Aug 26, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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